Gloucester lymphoma drug fast-tracked

CAMBRIDGE, Mass., May 16 (UPI) -- U.S. firm Gloucester Pharmaceuticals said Wednesday it has been granted fast-track status for its drug romidepsin for peripheral T-Cell lymphoma.

The company said it is studying the histone deacetylase inhibitor as a monotherapy in patients with previously treated PTCL.

Gloucester said interim results from a phase 2 study of the new treatment involving 36 patients showed an overall response rate of 30 percent, with three patients experiencing complete responses, and eight seeing partial response.

Fast-track status -- reserved for drugs for serious illnesses for which there is an unmet medical need -- means the Food and Drug Administration will likely complete its review of the drug within six months, and the company can use data from an earlier point in the trial -- called surrogate endpoints -- to show safety and efficacy.

The new treatment also has orphan drug status, aimed at drugs for rare diseases, which means that if it gets approval, Gloucester would have six months' market exclusivity for the product.